Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs)
This study has been completed.
Sponsor:
BridgePoint Medical
Information provided by (Responsible Party):
BridgePoint Medical
ClinicalTrials.gov Identifier:
NCT00886899
First received: April 21, 2009
Last updated: March 15, 2012
Last verified: March 2012
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Purpose
Prospective, non-randomized, multicenter study in subjects with coronary artery chronic total occlusions (CTOs). Published results of safety and effectiveness of conventional techniques will be used for comparison. Enrollment of up to 149 subjects with a CTO refractory to currently marketed guidewire use and meeting all inclusion/exclusion criteria at up to 15 US clinical sites. Hypothesis is that the BridgePoint Medical System is safe and effective in treating coronary CTOs compared to CTO literature.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Chronic Total Occlusion |
Device: Recanalization of a coronary chronic total occlusion |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Facilitated Antegrade Steering Technique in Chronic Total Occlusions |
Resource links provided by NLM:
Further study details as provided by BridgePoint Medical:
Primary Outcome Measures:
- Technical Success [ Time Frame: Intraprocedural ] [ Designated as safety issue: No ]Defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a chronic total occlusion (CTO) in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire
- 30-day Major Adverse Cardiac Event (MACE) Rate [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]Defined as cardiac death, Q-wave and non-Q-wave [total creatinine kinase (CK) >2x upper limit of normal with a positive myocardial band (MB) fraction] myocardial infarction (MI), target lesion revascularization (TLR), and emergency bypass surgery.
Secondary Outcome Measures:
- Total Procedure Time [ Time Frame: Intraprocedural ] [ Designated as safety issue: No ]Minus any time to determine CTO was refractory to standard guidewire
- Total Procedural Fluoroscopy Time [ Time Frame: Intraprocedural ] [ Designated as safety issue: No ]Minus any time to determine CTO was refractory to standard guidewire
| Enrollment: | 147 |
| Study Start Date: | March 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BridgePoint Medical System
Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
|
Device: Recanalization of a coronary chronic total occlusion
Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- suitable candidate for non-emergent, coronary angioplasty
- documented coronary CTO lesion with the following characteristics: a) Thrombolysis in Myocardial Infarction (TIMI) 0 flow for at least 90 days; b) satisfactory distal vessel visualization; and c) refractory to currently marketed guidewire crossing via 1 of the following: 1. previous failed attempt to cross CTO within the past 12 months; or 2. unsuccessful CTO crossing w/ guidewire (10-15 min fluoro time); or 3. attempt to cross CTO w/ guidewire results in subintimal guidewire
- angina or ischemia caused by the occluded artery
- at least 18 years of age
- Body Mass Index (BMI) < 40
- left ventricle ejection fraction > 20%
- sign the Informed Consent Form
Exclusion Criteria:
- saphenous vein graft (SVG) CTO or an in-stent CTO
- aorto-ostial CTO location. (Ostial bifurcation origins may be considered)
- intolerance to aspirin or a neutropenic response to Ticlopidine/Clopidogrel
- appearance of thrombus or intraluminal filling defects
- severe cerebrovascular disease (history of stroke or TIA within 1 month)
- cardiac intervention within two weeks of the procedure
- renal insufficiency (serum creatinine of > 2.3 mg/dl)
- active gastrointestinal bleeding
- active infection or fever that may be due to infection
- life expectancy < 2 years due to other illnesses
- significant anemia (hemoglobin < 8.0 mg / dl)
- severe uncontrolled systemic hypertension
- severe electrolyte imbalance
- anaphylaxis to angiographic contrast media unless appropriately medicated
- congestive heart failure [New York Heart Association (NYHA) Class IV]
- unstable angina requiring emergent percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
- recent myocardial infarction (MI)(within the past two weeks)
- uncontrolled diabetes
- participation in another investigational protocol
- unwillingness or inability to comply with any protocol requirements
- pregnant or nursing
- extensive dissection from refractory guidewire use
- crossing CTO (true lumen) w/ guidewire within 10-15 min of fluoro time
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886899
Locations
| United States, Arizona | |
| St. Luke's Medical Center | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Scripps Clinic | |
| La Jolla, California, United States, 92037 | |
| University of California Davis Heart & Vascular Center | |
| Sacramento, California, United States, 95817 | |
| Stanford University Hospital | |
| Stanford, California, United States, 94305 | |
| Torrance Memorial Medical Center | |
| Torrance, California, United States, 90505 | |
| United States, Connecticut | |
| Yale-New Haven Hospital | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Illinois | |
| Prairie Cardiovascular Consultants | |
| Springfield, Illinois, United States, 62701 | |
| United States, Minnesota | |
| Minneapolis Heart Institute, Abbott Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| Mayo Clinic - St. Mary's Hospital | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Mid America Heart Institute, St. Luke's Hospital | |
| Kansas City, Missouri, United States, 64111 | |
| United States, New Hampshire | |
| Dartmouth Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| Dallas VA Medical Center | |
| Dallas, Texas, United States, 75216 | |
| United States, Utah | |
| Intermountain Medical Center | |
| Murray, Utah, United States, 84157 | |
| United States, Washington | |
| St. Joseph Hospital | |
| Bellingham, Washington, United States, 98225 | |
Sponsors and Collaborators
BridgePoint Medical
Investigators
| Principal Investigator: | Patrick Whitlow, MD | The Cleveland Clinic |
More Information
No publications provided by BridgePoint Medical
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | BridgePoint Medical |
| ClinicalTrials.gov Identifier: | NCT00886899 History of Changes |
| Other Study ID Numbers: | 200-0002 |
| Study First Received: | April 21, 2009 |
| Results First Received: | February 21, 2012 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by BridgePoint Medical:
|
CTO chronic total occlusion CAD coronary artery disease |
interventional cardiology revascularization recanalization |
ClinicalTrials.gov processed this record on May 16, 2013